Stable redox compositions and methods of use

ABSTRACT

Described herein are compositions that include a saline solution and reactive oxygen species. Specifically, the composition may include a saline solution, reactive oxygen species, an emollient, and a pH modifier. Also provided is a gel composition that includes a rheology agent. Also provided are methods of making and using the compositions.

RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 16/125,344, filed on Sep. 7, 2018, which claims thebenefit of priority to U.S. Provisional Patent Application No.62/609,714, filed Dec. 22, 2017, the disclosure of which is incorporatedby reference herein in its entirety.

FIELD

The present disclosure relates to stable redox compositions that includea saline solution, a reactive oxygen species, an emollient, and a pHmodifying agent, wherein the saline solution includes a salt. Alsoprovided are compositions that further include a rheology agent. Thedisclosure also relates to methods of making and using the compositions.

BACKGROUND

Salinated compositions having reactive oxygen species are frequentlyused for cosmetic, personal, medicinal, or industrial uses. A widevariety of formulations are known, and may include, for example,formulations for topical application for improving the appearance ofskin, for preventing skin aging, for moisturizing, for wound healing, orfor general applications.

Reactive oxygen species (ROS) are important in a variety of fields. Inmedicine there is evidence linking ROS to the aging, disease processes,and the reduction of oxidative stress. Furthermore, ROS are employed asmicrobicidal agents in the home, hospital, and other settings.

There is a need in the art for improved formulations that includereactive oxygen species, such that the formulation is stable, effective,and has desirable characteristics.

SUMMARY

The present disclosure is directed to compositions having reactiveoxygen species and methods of making and using the same.

In some embodiments, the composition includes a saline solution, areactive oxygen species, an emollient, and a pH modifying agent. In someembodiments, the composition further includes a rheology agent. In someembodiments, the saline solution includes salt in an amount of about0.001% to about 15% w/v, such as 0.001%, 0.005%, 0.01%, 0.02%, 0.03%,0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%,0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 1.5%, 2.0%, 2.5%, 3.0%, 3.5%, 4.0%, 4.5%,5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, or 15% w/v or an amountwithin a range defined by any two of the aforementioned values. In someembodiments, the salt is purified or refined salt, such as table salt.In some embodiments, the salt is raw, unprocessed salt. In someembodiments, the salt is Himalayan sea salt.

In some embodiments, the reactive oxygen species includes superoxides(O₂*⁻, HO_(2*)), hypochlorites (OCl⁻, HOCl, NaClO), hypochlorates(HClO₂, ClO₂, HClO₃, HClO₄), oxygen derivatives (O₂, O₃, O₄*, O),hydrogen derivatives (H₂, H⁻), hydrogen peroxide (H₂O₂), hydroxyl freeradical (OH*⁻), ionic compounds (Na⁺, Cl⁻, H⁺, OH⁻, NaCl, HCl, NaOH),chlorine (Cl₂), water clusters (n*H₂O—induced dipolar layers aroundions), and combinations thereof. In some embodiments, the reactiveoxygen species is hypochlorite. In some embodiments, the reactive oxygenspecies is present in an amount of about 5 to about 100 ppm, such as 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95,or 100 ppm, or an amount within a range defined by any two of theaforementioned values.

In some embodiments, the emollient is a silicone polymer or blendthereof, such as dimethicone, cyclomethicone, or a blend thereof. Insome embodiments, the emollient is present in an amount of about 0.5% toabout 10% w/v, such as 0.5%, 1.0%, 1.5%, 2.0%, 2.5%, 3.0%, 3.5%, 4.0%,4.5%, 5.0%, 5.5%, 6.0%, 6.5%, 7.0%, 7.5%, 8.0%, 8.5%, 9.0%, 9.5%, or10.0% w/v, or an amount within a range defined by any two of theaforementioned values. In some embodiments, the pH modifying agent is abuffer, a base, or an acid, such as sodium phosphate monobasic. In someembodiments, the pH modifying agent is present in an amount of about0.05% to about 5% w/v, such as 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%,0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 1.5%, 2.0%, 2.5%, 3.0%, 3.5%, 4.0%, 4.5%,or 5.0% w/v, or an amount within a range defined by any two of theaforementioned values.

In some embodiments, the rheology agent is sodium magnesium silicate. Insome embodiments, the rheology agent is present in an amount of about0.5% to about 10% w/v, such as 0.5%, 1.0%, 1.5%, 2.0%, 2.5%, 3.0%, 3.5%,4.0%, 4.5%, 5.0%, 5.5%, 6.0%, 6.5%, 7.0%, 7.5%, 8.0%, 8.5%, 9.0%, 9.5%,or 10.0% w/v, or an amount within a range defined by any two of theaforementioned values.

In some embodiments, the composition includes a saline solution havingsalt in an amount of about 0.05% w/v, hypochlorite in an amount of about72 ppm, sodium magnesium silicate in an amount of about 3.25% w/v, asilicone polymer in an amount of about 5% w/v, and sodium phosphatemonobasic in an amount of about 0.3% w/v.

In some embodiments, the composition is formulated as a gel, sol,sol-gel, hydrogel, cream, foam, balm, liniment, unguent, colloid,emulsion, dispersion, salve, emollient, lotion, meltable solid, mousse,ointment, paste, serum, solution, a liquid, spray, stick, or suspension.

Some embodiments relate to methods of making one or more of thecomposition disclosed herein. In some embodiments, the method includesproviding a saline solution having reactive oxygen species therein, andmixing an emollient with the saline solution. In some embodiments, thesaline solution having reactive oxygen species could be made byelectrolyzing a saline solution. In some embodiments, the method furtherincludes making a gel composition by further providing a rheology agentand mixing the rheology agent with the saline solution.

Some embodiments provided herein relate to methods of using thecomposition as described herein. In some embodiments, the methodincludes administering or applying an amount of a composition to asubject in need thereof. In some embodiments, the composition isformulated for ingestion, for injection, or for topical application.Some embodiments provided herein relate to methods of using acomposition. In some embodiments, the methods include administering thecomposition as described herein to a subject. In some embodiments, themethods include providing the composition as described herein in atopical formulation to a subject.

DETAILED DESCRIPTION

Embodiments provided herein related to a reactive oxygen salinatedcomposition. In some embodiments, the composition includes a salinesolution, a reactive oxygen species, an emollient, and a pH modifier. Insome embodiments, the composition further includes a rheology agent.Also provided are methods of making and methods of using thecomposition.

It will be readily understood that the aspects of the presentdisclosure, as generally described herein, can be arranged, substituted,combined, separated, and designed in a wide variety of differentconfigurations, all of which are explicitly contemplated herein.

Unless defined otherwise, technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the present disclosure belongs. All patents,applications, published applications and other publications referencedherein are expressly incorporated by reference in their entiretiesunless stated otherwise. For purposes of the present disclosure, thefollowing terms are defined below.

By “about” is meant a quantity, level, value, number, frequency,percentage, dimension, size, amount, weight or length that varies by asmuch as 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 or 1% to a referencequantity, level, value, number, frequency, percentage, dimension, size,amount, weight or length. When a value is preceded by the term about,the component is not intended to be limited strictly to that value, butit is intended to include amounts that vary from the value.

Throughout this specification, unless the context requires otherwise,the words “comprise,” “comprises,” and “comprising” will be understoodto imply the inclusion of a stated step or element or group of steps orelements but not the exclusion of any other step or element or group ofsteps or elements.

I. Redox Compositions

Some embodiments provided herein relate to a reactive oxygen salinatedcomposition. As used herein, the term “composition” or “formulation” asused herein refers to a combination of elements, components, orcompositions presented together for a given purpose.

In some embodiments, the “purity” of any given agent (for example,hypochlorous acid or a buffer) in a composition may be specificallydefined. For instance, certain compositions may include, for example, anagent that is at least 80, 85, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99,or 100% pure, including all decimals in between, as measured, forexample and by no means limiting, by analytical chemistry techniques.

As used herein, the term “saline solution” refers to a solution having aquantity of salt. In some embodiments, the saline solution includes apurified or refined salt. In some embodiments, the saline solutionincludes a raw or unprocessed salt. In some embodiments, the salt ishalite, table salt, refined salt, curing salt, flake salt, Epsom salt,sea salt, Alaea salt (or Hawaiian sea salt), Alpenbergkern salt,Anglesey Sea salt, Celtic sea salt, Dead Sea salt, Himalayan sea salt(including Himalayan pink sea salt), Kalahari salt, Maras salt, MurrayRiver salt flakes, Namibian salt pearls, Persian blue fine salt, Polishmine salt, primordial sea salts, Sal de Tavira, Sale Marino di Trapani,Sel de Guérande, South African Sea salt, Utah salt, black lava salt,brine, rock salt, red rock salt, fleur de sel, or kosher salt. The saltpresent in the saline solution can include a number of elements,including actinium, aluminum, antimony, arsenic, astatine, barium,beryllium, bismuth, boron, bromine, cadmium, calcium, carbon, cerium,cesium, chlorine, chromium, cobalt, copper, dysprosium, erbium,europium, francium, fluorine, gadolinium, gallium, germanium, gold,hafnium, holmium, hydrogen, iodine, indium, iridium, iron, lanthanum,lead, lithium, lutetium, magnesium, manganese, mercury, molybdenum,neptunium, neodymium, nickel, niobium, nitrogen, osmium, oxygen,palladium, phosphorus, platinum, plutonium, polonium, potassium,praseodymium, promethium, protactinium, radium, rhenium, rhodium,rubidium, ruthenium, samarium, scandium, selenium, silicon, silver,sodium, strontium, sulfur, tantalum, technetium, tellurium, terbium,thallium, thorium, thulium, tin, titanium, uranium, vanadium, ytterbium,zinc, or zirconium. In some embodiments, the element present in the saltcan be present in an amount of less than 0.001 ppm to an amount ofgreater than 400,000 ppm. In some embodiments, the saline solutionincludes salt in an amount of 0.001, 0.005, 0.01, 0.02, 0.03, 0.04,0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8,0.9, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5, 6, 7, 8, 9, 10, 11, 12,13, 14, or 15% (w/v), or an amount within a ranged defined by any two ofthe aforementioned values. In some embodiments, the saline solutionincludes salt in an amount of 0.05%.

As used herein, the term “reactive oxygen species (ROS)” refers tochemically reactive molecules containing oxygen. Examples include ozone,peroxides, active chlorines, active oxygens, superoxides, activehydrogens, hydroxyl radical, and singlet oxygen. ROS are formed as anatural byproduct of the normal metabolism of oxygen and have importantroles in cell signaling and homeostasis. ROS can include, but are notlimited to superoxides (O₂*⁻, HO_(2*)), hypochlorites (OCl⁻, HOCl,NaClO), hypochlorates (HClO₂, ClO₂, HClO₃, HClO₄), oxygen derivatives(O₂, O₃, O₄*⁻, O), hydrogen derivatives (H₂, H), hydrogen peroxide(H₂O₂), hydroxyl free radical (OH*), ionic compounds (Na⁺, Cl⁻, H⁺, OH⁻,NaCl, HCl, NaOH), chlorine (Cl₂), water clusters (n*H₂O—induced dipolarlayers around ions), and combinations thereof. Some ROS can be electronacceptors and some can be electron donors. In some embodiments, areactive oxygen species is a hypochlorite. In one embodiment, thecomposition can include at least one reactive oxygen species such as O₂,H₂, Cl₂, OCl⁻, HOCl, NaOCl, HClO₂, ClO₂, HClO₃, HClO₄, H₂O₂, Na⁺, Cl⁻,H⁺, OH⁻, O₃, O₄*⁻, ¹O, OH*⁻, HOCl—O₂*⁻, HOCl—O₃, O₂*⁻, HO₂*, NaCl, HCl,NaOH, water clusters, or a combination thereof.

Redox signaling deals with the action of a set of several simplereactive signaling molecules that are mostly produced by mitochondriaresiding inside cells during the metabolism of sugars. These reactivesignaling molecules are categorized into two general groups, ROS, whichcontain oxidants, and reduced species (RS), which contain reductants.These fundamental universal signaling molecules in the body are thesimple but extremely important reactive signaling molecules that areformed from combinations of the atoms (Na, Cl, H, O, N) that are readilyfound in the saline bath that fills the inside of the cells (cytosol).All of the molecular mechanisms inside healthy cells float around inthis saline bath and are surrounded by a balanced mixture of suchreactive signaling molecules. A few examples of the more than 20reactive molecules formed from these atoms inside the cell, some ofwhich are discussed herein, are superoxide, hydrogen peroxide,hypochlorite, and nitric oxide.

Such reactive signaling molecules are chemically broken down byspecialized enzymes placed at strategic locations inside the cell. Someof these protective enzymes are classified as antioxidants such asglutathione peroxidase and superoxide dismutase. In a healthy cell, themixtures of these reactive signaling molecules are broken down by theantioxidant enzymes at the same rate that they are produced by themitochondria. As long as this homeostatic balance is maintained, thecell's chemistry is in balance and all is well.

When damage occurs to the cell, for any number of reasons, includingbacterial or viral invasion, DNA damage, physical damage or toxins, thishomeostatic balance is disturbed and a build-up of oxidants orreductants occurs in the cell. This condition is known as oxidativestress and it acts as a clear signal to the cell that something iswrong. The cell reacts to this signal by producing the enzymes andrepair molecules necessary to attempt repairs to the damage and it alsocan send messengers to activate the immune system to identify andeliminate threats. If oxidative stress persists in the cell for morethan a few hours, then the cell's repair attempts are consideredunsuccessful and the cell kills and dismantles itself and is replaced bythe natural cellular division of healthy neighboring cells.

On a cellular level, this is essentially the healthy tissue maintenanceprocess: damaged cells are detected and repaired or replaced by healthycells. This cellular repair and regeneration process is constantlytaking place, millions of times an hour, in all parts of the body.

In one embodiment, the composition can include at least one reactiveoxygen species such as H₂, Cl₂, OCl⁻, HOCl, NaOCl, HClO₂, ClO₂, HClO₃,HClO₄, H₂O₂, O₃, O₄*⁻, ¹O₂, OH*⁻, HOCl—₂*⁻, HOCl—O₃, O₂*⁻, HO₂*, waterclusters, or a combination thereof.

In one embodiment, the composition can include at least one reactiveoxygen species such as HClO₃, HClO₄, H₂O₂, O₃, O₄*⁻, ¹O₂, OH*⁻,HOCl—O₂*⁻, HOCl—O₃, O₂*⁻, HO₂*, water clusters, or a combinationthereof. In one embodiment, the composition can include at least O₂*—and HOCl.

In one embodiment, the composition can include O₂. In one embodiment,the composition can include Hz. In one embodiment, the composition caninclude Cl₂. In one embodiment, the composition can include OCl⁻. In oneembodiment, the composition can include HOCl. In one embodiment, thecomposition can include NaOCl. In one embodiment, the composition caninclude HClO₂. In one embodiment, the composition can include ClO₂. Inone embodiment, the composition can include HClO₃. In one embodiment,the composition can include HClO₄. In one embodiment, the compositioncan include H₂O₂. In one embodiment, the composition can include Na⁺. Inone embodiment, the composition can include Cl⁻. In one embodiment, thecomposition can include H⁺. In one embodiment, the composition caninclude H⁻. In one embodiment, the composition can include OH⁻. In oneembodiment, the composition can include O₃. In one embodiment, thecomposition can include O₄*⁻. In one embodiment, the composition caninclude ¹O₂. In one embodiment, the composition can include OH*⁻. In oneembodiment, the composition can include HOCl—O₂*⁻. In one embodiment,the composition can include HOCl—O₃. In one embodiment, the compositioncan include O₂*⁻. In one embodiment, the composition can include HO₂*.In one embodiment, the composition can include NaCl. In one embodiment,the composition can include HCl. In one embodiment, the composition caninclude NaOH. In one embodiment, the composition can include waterclusters. Embodiments can include combinations thereof.

“Hypochlorous acid”, as used herein, refers to a weak acid having thechemical formula HClO. Hypochlorous acid is also known as chloric (I)acid, chloranol, or hydroxidochlorine. Hypochlorite includes ions ofhypochlorous acid (for example, OCl⁻). Salts of hypochlorite are alsoreferred to herein and can include sodium hypochlorite (NaClO), calciumhypochlorite (Ca(ClO)₂), or potassium hypochlorite (KClO). Hypochlorite,or acids and salts thereof, may be present in the compositions describedherein in an amount of 0.001%, 0.005%, 0.01%, 0.02%, 0.03%, 0.04%,0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 1%, 5%,10%, 15%, 20%, 25%, 30%, 40%, 50%, or greater w/v %, or within a rangedefined by any two of the aforementioned amounts. In some embodiments,the w/v % of hypochlorite or an acid or salt thereof is 0.072% w/v. Insome embodiments, the hypochlorite, or salt or acid thereof, is addeddirectly to a composition. In some embodiments, the hypochlorite, oracid or salt thereof, is generated in the composition by electrolysis.In some embodiments, the final amount of hypochlorite is less than,greater than, or equal to about 10, 15, 20, 25, 30, 35, 40, 45, 50, 55,60, 65, 70, 75, 80, 85, 90, 95, 100, 120, 150, 175, 200, 300 ppm orwithin a range defined by any two of the aforementioned amounts. In someembodiments, the amount of hypochlorite in the composition is betweenabout 50 to about 100 ppm. In some embodiments, the amount ofhypochlorite in the composition is about 72 ppm.

As used herein, an “emollient” refers to a compound that soothes theskin. In some embodiments, an emollient is a moisturizer, a cream, alotion, an oil, a rub, a salve, an unguent, or a balm. In someembodiments, the emollient is a silicone polymer. In some embodiments,the silicone polymer is dimethicone, which is also referred to aspolydimethylsiloxane (PDMS), dimethylpolysiloxane, E900, or polymerizedsiloxane and has the chemical formula of CH₃[Si(CH₃)₂O]_(n)Si(CH₃)₃where n is the number of repeating monomer [Si(CH₃)₂] units. Siliconepolymers also include cyclomethicone, which is a cyclic siloxane. Insome embodiments, the silicone polymer used in the composition is ablend of dimethicone and cyclomethicone. In some embodiments, thesilicone polymer is dimethicone satin, a mixture of low and highmolecular weight linear silicones. In some embodiments, the siliconepolymer is amodimethicone, cyclo-dimethicone, cyclomethicone,dimethicone 500, dimethicone satin, iso-dimethicone copolymer, or blendsthereof. In some embodiments, a silicone polymer acts as a moisturizer,a slip agent, or a lubricant. The emollient may be present in thecomposition in an amount of about 0.5%, 1%, 5%, 10%, 15%, 20%, 30%, 40%,50%, or greater w/v %, or in an amount within any two of theaforementioned values or between a range defined by these values. Insome embodiments, the amount of silicone polymer is about 5% w/v.

As used herein, the term “pH modifier” refers to an acid, base, or agentthat may be used to change or stabilize the pH of a composition. A pHmodifier may include an agent for modifying the pH of a solution orcomposition, such as an acid or a base, including, for example, mineralacids such as hydrochloric acid, phosphoric acid and sulfuric acid,organic acids such as benzoic acid, citric acid, lactic acid, maleicacid, malic acid, tartaric acid, adipic acid, gluconic acid and theirsalts and bases such as sodium hydroxide and potassium hydroxide. Insome embodiments, a pH modifier may include an agent for stabilizing thepH of a solution or composition at a desired pH, including for example,a buffer such as a sodium acetate, acetate, citrate, or phosphatebuffer. In some embodiments, the pH modifier is sodium phosphatemonobasic. In some embodiments, the pH modifier is present in an amountof about 0.001%, 0.005%, 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%,0.07%, 0.08%, 0.09%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%,0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, or 15% w/v, or an amountwithin a range defined by any two of the aforementioned values. In someembodiments, the pH modifier is present in an amount of about 0.3% w/v.As used herein, the pH of the composition is the numerical scale tospecify the acidity or basicity of the composition. In some embodiments,the pH of the composition is about 5.0 to about 8.5, such as 5.0, 5.5,6.0, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7,7.8, 7.9, 8.0, or 8.5, or within a ranged defined by any two of theaforementioned values. In some embodiments, the pH of the composition isin a range from about 6.0 to about 7.8.

In some embodiments, the composition described herein have osmolalitymeasurement values of about 0.5 to 100 mOsm/kg, such as 0.5, 1, 1.5, 2,2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 15, 20,25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 80, 90, or 100 mOsm/kg, orwithin a range defined by any two of the aforementioned values. In someembodiments, the compositions have osmolality measurement vales of about3 to 5 mOsm/kg.

In some embodiments, the composition further includes a rheology agent.As used herein, the term “rheology agent” refers to a substance thatmodulates the viscosity of a composition, without modifying otherproperties of the composition. In some embodiments, the rheology agentacts as a thickener by increasing the viscosity of the composition. Insome embodiments, the rheology agent can include a metal silicate. Insome embodiments, the rheology agent is sodium magnesium silicate, asilicate of sodium and magnesium. In some embodiments, sodium magnesiumsilicate is a synthetic silicate clay, having magnesium and sodiumsilicate. In some embodiments, a rheology agent is used as a binder andbulking agent in cosmetics and personal care products, in part becauseof its ability to absorb water. Sodium magnesium silicate is effectivein slowing the decomposition of formulas, and can prevent prematuredarkening of compositions and prevent premature development of a foulodor, thereby improving the shelf life of cosmetic compositions. In someembodiments, the sodium magnesium silicate is Laponite, including forexample, Laponite XL21™, Laponite RD™, Laponite RDS™, Laponite S482™,Laponite SL25™, Laponite EP™, Laponite JS™, Laponite XLS™, Laponite D™,or Laponite XLG™. The rheology agent may be used in the composition inan amount of about 0.1%, 0.25%, 0.5%, 0.75%, 1%, 1.5%, 2%, 2.5%, 3%,3.5%, 4%, 4.5%, 5%, 6%, 7%, 10%, 15%, or greater w/v %, or in an amountwithin any two of the aforementioned values or between a range definedby these values. In some embodiments, the amount of rheology agent isabout 3% w/v.

In some embodiments, the viscosity of the composition can be anysuitable viscosity for the mode of administration. Thus, for oraladministration, such as when the composition is formulated as a liquidfor oral administration, the viscosity is similar to the viscosity ofpure water. In some embodiments, the composition is a suitable viscositysuch that the composition can be topically applied to a subject. In someembodiments, the viscosity of the composition can be in the range ofabout 1 to about 100,000 centipoise (cP). In some embodiments, theviscosity of the composition can be 1, 100 cP, 200 cP, 300 cP, 400 cP,500 cP, 600 cP, 700 cP, 800 cP, 900 cP, 1,000 cP, 2,000 cP, 3,000 cP,4,000 cP, 5,000 cP, 10,000 cP, 15,000 cP, 20,000 cP, 25,000 cP, 30,000cP, 35,000 cP, 40,000 cP, 45,000 cP, 50,000 cP, 55,000 cP, 60,000 cP,65,000 cP, 70,000 cP, 75,000 cP, 80,000 cP, 85,000 cP, 90,000 cP, or95,000 cP. In some embodiments, the viscosity of the composition can bein the range of about 100 to 20,000 cP, or 1,000 cP to about 20,000 cP.In other embodiments, the viscosity of the composition can be in therange of about 12,000 cP to about 20,000 cP. These viscosity ranges canbe approximate and can be modified to achieve specific characteristicsdesired and/or required in the composition.

The compositions described herein may further include an additive knownin the art. In some embodiments, the additive includes a compound thatimproves the composition for the mode of administration. In someembodiments, the additive improves the efficacy of the composition. Insome embodiments, the additive improves the shelf life of thecomposition. In some embodiments, the additive is included for aestheticpurposes to improve the appearance, texture, scent, or feel of thecomposition. Exemplary additives for including in the compositionsdescribed herein include moisturizers, humectants, pigments, dyes,pearlescent compounds, nacreous pigments, bismuth oxychloride coatedmica, titanium dioxide coated mica, colorants, fragrances, biocides,preservatives, lipolytic agent, diuretics, xanthines (such as caffeine,theophylline, and aminophylline), alpha hydroxy acids, antioxidants,lymphatic drainage agent, antiperspirant agents, exfoliants, hormones,enzymes, medicinal compounds, vitamins, minerals, electrolytes,alcohols, polyols, polypropylene glycol, retinoids, retinol,polyisobutene, polyoxyethylene, behenic acid, behenyl, sugar-alcohols,absorbing agents for ultraviolet radiation, botanical extracts,surfactants, silicone oils, organic oils, waxes, alkaline or acidic orbuffering agents, film formers, thickening agents, hyaluronic acid,fumed silica, hydrated silica, talc, kaolin, starch, modified starch,mica, nylon, clay, bentonite, organo-modified clays, and combinationsthereof.

Examples of exfoliants include, but are not limited to, alpha-hydroxyacids such as lactic acid, glycolic acid, malic acid, tartaric acid,citric acid, or any combination of any of the foregoing, beta-hydroxyacids such as salicylic acid, polyhydroxy acids such as lactobionic acidand gluconic acid, and mechanical exfoliation such as microdermabrasion.

In some embodiments, the composition is formulated as a gel, sol,sol-gel, hydrogel, cream, foam, balm, liniment, unguent, colloid,emulsion, dispersion, salve, emollient, lotion, meltable solid, mousse,ointment, paste, serum, solution, spray, stick, liquid, or suspension.

II. Method of Making the Composition

Some embodiments provided herein relate to a method of making thecomposition described herein. Methods of making the composition includeproviding a saline solution. In some embodiments, the saline solutionincludes a reactive oxygen species, which may either be directly addedto the saline solution or may be generated in the saline solution, forexample, by electrolysis of the saline solution. The method furtherincludes adding an emollient to the saline solution. In someembodiments, the method further includes adding a rheology agent to thesaline solution to generate a composition of a desired viscosity. Thedesired viscosity will depend upon the final composition and method ofapplication of the composition. For example, the desired viscosity maybe a low viscosity composition, or the desired viscosity may be a highviscosity composition.

The saline solution may include electrolyzing a saline solution having asalt concentration of about 10 g NaCl/gal, such as 10.75 g NaCl/galusing a set of electrodes with an amperage of about 50-60 amps, such as56 amps to produce an electrolyzed saline solution, wherein the water ischilled below room temperature and the water is circulated duringelectrolyzing. In some embodiments, the electrolysis is performedsufficient to generate a sufficient amount or concentration ofhypochlorite. In some embodiments, electrolysis is performed sufficientto generate an amount of hypochlorite ranging from 1 to 1000 ppm, suchas about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50,55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 120, 150, 175, 200, 300, 400,500, 600, 700, 800, 900, or 1000 ppm or an amount within a range definedby any two of the aforementioned amounts.

A method of producing the disclosed composition can include one or moreof the steps of (1) preparation of an ultra-pure homogeneous solution ofsodium chloride in water, (2) temperature control and flow regulationthrough a set of inert catalytic electrodes, and (3) a modulatedelectrolytic process that results in the formation of such stablemolecular moieties and complexes. In one embodiment, such a processincludes all these steps. In some embodiments, the method furtherincludes mixing a rheology agent with the electrolyzed saline solutionto a desired viscosity.

The saline generally should be free from contaminants, both organic andinorganic, and homogeneous down to the molecular level. In particular,metal ions can interfere with the electro-catalytic surface reactions,and thus it may be helpful for metals to be avoided. In one embodiment,a brine solution is used to salinate the water. The brine solution canhave a NaCl concentration of about 540 g NaCl/gal, such as 537.5 gNaCl/gal.

In one embodiment, the method of making a composition as describedherein can include reverse osmosis. As used herein, the term “reverseosmosis” refers to a process of extracting water through asemi-permeable membrane from feed water by applying on the feed water apressure that is higher than the osmotic pressure of the feed water.Water can be supplied from a variety of sources, including but notlimited to municipal water, filtered water, distilled water, nanopurewater, or the like.

The reverse osmosis process can vary, but can include providing waterhaving a total dissolved solid content of less than about 10 ppm, suchas about 9 ppm, about 8 ppm, about 7 ppm, about 6 ppm, about 5 ppm,about 4 ppm, about 3 ppm, about 2 ppm, about 1 ppm or less.

The reverse osmosis process can be performed at a temperature of about5° C., about 10° C., about 15° C., about 20° C., about 25° C., about 30°C., about 35° C., or a temperature within a range defined by any two ofthe aforementioned values. The reverse osmosis step can be repeated asneeded to achieve a particular total dissolved solids level. In someembodiments, a distillation step can also be performed, prior to, after,or concomitant with the reverse osmosis step. Distillation as usedherein refers to a process boiling water and condensing steam into aseparate container to obtain distilled water. Distilled water includeswater that is purified to remove minerals such as calcium and magnesium,trace elements, or other impurities by distillation. In someembodiments, distilled water is purchased and used in one or more of theabove processes.

Other means of reducing contaminants include filtration and/orpurification such as by utilizing deionization, carbon filtration,double-distillation, electrodeionization, resin filtration such as withMilli-Q purification, microfiltration, ultrafiltration, ultravioletoxidation, electrodialysis, or combinations thereof.

The distillation process can vary, but can provide water having a totaldissolved solid content of less than about 5 ppm, about 4 ppm, about 3ppm, about 2 ppm, about 1 ppm, about 0.9 ppm, about 0.8 ppm, about 0.7ppm, about 0.6 ppm, about 0.5 ppm, about 0.4 ppm, about 0.3 ppm, about0.2 ppm, about 0.1 ppm, or less, or an amount within a range defined byany two of the aforementioned values. The temperature of thedistillation process can be performed at a temperature of about 5° C.,about 10° C., about 15° C., about 20° C., about 25° C., about 30° C.,about 35° C., or a temperature within a range defined by any two of theaforementioned values.

The distillation step can be repeated as needed to achieve a particulartotal dissolved solids level. After water has been subjected to reverseosmosis, distillation, both, or neither, the level of total dissolvedsolids in the water can be less than about 5 ppm, about 4 ppm, about 3ppm, about 2 ppm, about 1 ppm, about 0.9 ppm, about 0.8 ppm, about 0.7ppm, about 0.6 ppm, about 0.5 ppm, about 0.4 ppm, about 0.3 ppm, about0.2 ppm, about 0.1 ppm, or less, or an amount within a range defined byany two of the aforementioned values.

The reverse osmosis, distillation, both, or neither, can be preceded bya carbon filtration step. Purified water can be used directly with thesystems and methods described herein.

In one embodiment, contaminants can be removed from a commercial sourceof water by the following procedure: water flows through an activatedcarbon filter to remove the aromatic and volatile contaminants and thenundergoes reverse osmosis (RO) filtration to remove dissolved solids andmost organic and inorganic contaminants. The resulting filtered RO watercan contain less than about 8 ppm of dissolved solids. Most of theremaining contaminants can be removed through a distillation process,resulting in dissolved solid measurements less than 1 ppm. In additionto removing contaminants, distillation may also serve to condition thewater with the correct structure and oxidation reduction potential (ORP)to facilitate the oxidative and reductive reaction potentials on theplatinum electrodes in the subsequent electro-catalytic process.

After water has been subjected to reverse osmosis, distillation, both orneither, a salt can be added to the water in a salting step. The saltcan be unrefined, refined, caked, de-caked, or the like. In someembodiments, the salt is halite, table salt, refined salt, curing salt,flake salt, Epsom salt, sea salt, Alaea salt (or Hawaiian sea salt),Alpenbergkern salt, Anglesey Sea salt, Celtic sea salt, Dead Sea salt,Himalayan sea salt (including Himalayan pink sea salt), Kalahari salt,Maras salt, Murray River salt flakes, Namibian salt pearls, Persian bluefine salt, Polish mine salt, primordial sea salts, Sal de Tavira, SaleMarino di Trapani, Sel de Guérande, South African Sea salt, Utah salt,black lava salt, brine, rock salt, red rock salt, fleur de sel, orkosher salt. The salt present in the composition can include a number ofelements, including actinium, aluminum, antimony, arsenic, astatine,barium, beryllium, bismuth, boron, bromine, cadmium, calcium, carbon,cerium, cesium, chlorine, chromium, cobalt, copper, dysprosium, erbium,europium, francium, fluorine, gadolinium, gallium, germanium, gold,hafnium, holmium, hydrogen, iodine, indium, iridium, iron, lanthanum,lead, lithium, lutetium, magnesium, manganese, mercury, molybdenum,neptunium, neodymium, nickel, niobium, nitrogen, osmium, oxygen,palladium, phosphorus, platinum, plutonium, polonium, potassium,praseodymium, promethium, protactinium, radium, rhenium, rhodium,rubidium, ruthenium, samarium, scandium, selenium, silicon, silver,sodium, strontium, sulfur, tantalum, technetium, tellurium, terbium,thallium, thorium, thulium, tin, titanium, uranium, vanadium, ytterbium,zinc, or zirconium. In some embodiments, the element present in the saltcan be present in an amount of less than 0.001 ppm to an amount ofgreater than 400,000 ppm.

In some embodiments, the salt includes aluminum in an amount of 114.8ppm, antimony in an amount of 0.022 ppm, arsenic in an amount of 0.066ppm, barium in an amount of 0.664 ppm, beryllium in an amount of 0.051ppm, bismuth in an amount of 0.005 ppm, bromine in an amount of 56.006ppm, cadmium in an amount of 0.017 ppm, calcium in an amount of 2101.000ppm, chromium in an amount of 0.207 ppm, cobalt in an amount of 0.033ppm, copper in an amount of 0.116 ppm, germanium in an amount of 0.072ppm, iodide in an amount of less than 0.001 ppm, iron in an amount of81.722 ppm, lead in an amount of 0.093 ppm, magnesium in an amount of1944.000 ppm, manganese in an amount of 1.911 ppm, mercury in an amountof 0.016 ppm, molybdenum in an amount of 0.011 ppm, nickel in an amountof 0.096 ppm, phosphorus in an amount of 5.125 ppm, potassium in anamount of 1728.000 ppm, selenium in an amount of 0.269 ppm, silver in anamount of 0.004 ppm, sodium in an amount of 388690.000 ppm, strontium inan amount of 32.223 ppm, tin in an amount of 0.169 ppm, or zinc in anamount of 1.261 ppm or any combination thereof. In some embodiments, thesalt may include one or more of the above elements present in an amount1, 2, 3, 4, 5, 6, 7, 8, 9, or 10% higher or lower than the above-listedamounts.

In some embodiments, the salt includes aluminum in an amount of 32.473ppm, antimony in an amount of 0.013 ppm, arsenic in an amount of 0.046ppm, barium in an amount of 0.343 ppm, beryllium in an amount of 0.030ppm, bismuth in an amount of 0.004 ppm, bromine in an amount of 70.607ppm, cadmium in an amount of 0.010 ppm, calcium in an amount of 1290.000ppm, chromium in an amount of 0.195 ppm, cobalt in an amount of 0.013ppm, copper in an amount of 0.090 ppm, germanium in an amount of 0.085ppm, iodide in an amount of less than 0.001 ppm, iron in an amount of23.292 ppm, lead in an amount of 0.077 ppm, magnesium in an amount of1304.000 ppm, manganese in an amount of 1.040 ppm, mercury in an amountof 0.009 ppm, molybdenum in an amount of 0.014 ppm, nickel in an amountof 0.086 ppm, phosphorus in an amount of 3.548 ppm, potassium in anamount of 1174.000 ppm, selenium in an amount of 0.235 ppm, silver in anamount of 0.002 ppm, sodium in an amount of 391706.000 ppm, strontium inan amount of 18.328 ppm, tin in an amount of 0.135 ppm, or zinc in anamount of 1.045 ppm or any combination thereof. In some embodiments, thesalt may include one or more of the above elements present in an amount1, 2, 3, 4, 5, 6, 7, 8, 9, or 10% higher or lower than the above-listedamounts.

In some embodiments, the salt includes aluminum in an amount of 241.700ppm, antimony in an amount of 0.026 ppm, arsenic in an amount of 0.076ppm, barium in an amount of 7.615 ppm, beryllium in an amount of 0.070ppm, bismuth in an amount of 0.006 ppm, bromine in an amount of 7.789ppm, cadmium in an amount of 0.024 ppm, calcium in an amount of 1860.000ppm, chromium in an amount of 0.175 ppm, cobalt in an amount of 0.058ppm, copper in an amount of 0.279 ppm, germanium in an amount of 0.092ppm, iodide in an amount of less than 0.001 ppm, iron in an amount of141.400 ppm, lead in an amount of 0.210 ppm, magnesium in an amount of217.900 ppm, manganese in an amount of 11.804 ppm, mercury in an amountof 0.012 ppm, molybdenum in an amount of 0.037 ppm, nickel in an amountof 0.113 ppm, phosphorus in an amount of 39.541 ppm, potassium in anamount of 149.300 ppm, selenium in an amount of 0.226 ppm, silver in anamount of 0.006 ppm, sodium in an amount of 390600.000 ppm, strontium inan amount of 11.251 ppm, tin in an amount of 0.177 ppm, or zinc in anamount of 1.883 ppm or any combination thereof. In some embodiments, thesalt may include one or more of the above elements present in an amount1, 2, 3, 4, 5, 6, 7, 8, 9, or 10% higher or lower than the above-listedamounts.

In some embodiments, the salt includes aluminum in an amount of 0.747ppm, antimony in an amount of 0.014 ppm, arsenic in an amount of 0.039ppm, barium in an amount of 0.012 ppm, beryllium in an amount of 0.038ppm, bismuth in an amount of 0.005 ppm, bromine in an amount of 81.414ppm, cadmium in an amount of 0.007 ppm, calcium in an amount of 10.625ppm, chromium in an amount of 0.027 ppm, cobalt in an amount of 0.001ppm, copper in an amount of 0.053 ppm, germanium in an amount of 0.081ppm, iodide in an amount of less than 0.001 ppm, iron in an amount of0.639 ppm, lead in an amount of 25.908 ppm, magnesium in an amount of3.753 ppm, manganese in an amount of 0.040 ppm, mercury in an amount of0.013 ppm, molybdenum in an amount of 0.007 ppm, nickel in an amount of0.016 ppm, phosphorus in an amount of 3.690 ppm, potassium in an amountof 60.756 ppm, selenium in an amount of 0.202 ppm, silver in an amountof 0.002 ppm, sodium in an amount of 391290.000 ppm, strontium in anamount of 0.230 ppm, tin in an amount of 0.166 ppm, or zinc in an amountof 0.791 ppm or any combination thereof. In some embodiments, the saltmay include one or more of the above elements present in an amount 1, 2,3, 4, 5, 6, 7, 8, 9, or 10% higher or lower than the above-listedamounts.

In some embodiments, the salt is included in an amount of 0.001, 0.005,0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3,0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5,6, 7, 8, 9, 10, 11, 12, 13, 14, or 15% (w/v), or an amount within aranged defined by any two of the aforementioned values.

In one embodiment, the salt is sodium chloride (NaCl), lithium chloride(LiCl), hydrogen chloride (HCl), copper chloride (CuCl₂), copper sulfate(CuSO₄), potassium chloride (KCl), magnesium chloride (MgCl), calciumchloride (CaCl₂), or sulfates or phosphates. In some embodiments, thesalt can include an additive. Salt additives can include, but are notlimited to potassium iodide, sodium iodide, sodium iodate, dextrose,sodium fluoride, sodium ferrocyanide, tricalcium phosphate, calciumcarbonate, magnesium carbonate, fatty acids, magnesium oxide, silicondioxide, calcium silicate, sodium aluminosilicate, calciumaluminosilicate, ferrous fumarate, iron, or folic acid. Any of theseadditives can be added at this point or at any point during thedescribed process. For example, the above additives can be added justprior to packaging the composition.

In another embodiment, the process can be applied to any ionic, solublesalt mixture, especially with those containing chlorides. In addition toNaCl, other non-limiting examples include LiCl, HCl, CuCl₂, CuSO₄, KCl,MgCl, CaCl₂, sulfates and phosphates. For example, strong acids such assulfuric acid (H₂SO₄), and strong bases such as potassium hydroxide(KOH), and sodium hydroxide (NaOH) are frequently used as electrolytesdue to their strong conducting abilities. Preferably the salt is sodiumchloride (NaCl). A brine solution can be used to introduce the salt intothe water. The amount of brine or salt may be apparent to one ofordinary skill in the art.

Salt can be added to water in the form of a brine solution. To mix thebrine solution, a physical mixing apparatus can be used or a circulationor recirculation can be used. In one embodiment, pure pharmaceuticalgrade sodium chloride is dissolved in the prepared distilled water toform a 15 wt. % sub-saturated brine solution and continuouslyre-circulated and filtered until the salt has completely dissolved andall particles >0.1 microns are removed. This step can take several days.In one embodiment, the filtered, dissolved brine solution can beinjected into tanks of distilled water in about a 1:352 ratio(salt:water) to form a 0.3% saline solution. In one embodiment, a ratio10.75 g of salt per 1 gallon of water can be used to form thecomposition. In another embodiment, 10.75 g of salt in about 3-4 g ofwater, such as 3,787.5 g of water can be used to form the composition.This solution then can be allowed to re-circulate and diffuse untilhomogeneity at the molecular scale has been achieved.

In one embodiment, the homogenous saline solution is chilled to about4.8±0.5° C. Temperature regulation during the entire electro-catalyticprocess is typically required as thermal energy generated from theelectrolysis process itself may cause heating. In one embodiment,process temperatures at the electrodes can be constantly cooled andmaintained at about 4.8° C. throughout electrolysis.

Brine can then be added to the previously treated water or to freshuntreated water to achieve a NaCl concentration of between about 1 gNaCl/gal water and about 25 g NaCl/gal water, between about 8 g NaCl/galwater and about 12 g NaCl/gal water, or between about 4 g NaCl/gal waterand about 16 g NaCl/gal water. Once brine is added to water at anappropriate amount, the solution can be thoroughly mixed. Thetemperature of the liquid during mixing can be at room temperature orcontrolled to a desired temperature or temperature range.

To mix the solution, a physical mixing apparatus can be used orcirculation or recirculation can be used. The salt solution can bechilled in a chilling step.

For large amounts of electrolyzed solution, various chilling and coolingmethods can be employed. For example cryogenic cooling using liquidnitrogen cooling lines can be used. Likewise, the solution can be runthrough propylene glycol heat exchangers to achieve the desiredtemperature. The chilling time can vary depending on the amount ofliquid, the starting temperature and the desired chilled temperature.

Products from the anodic reactions can be effectively transported to thecathode to provide the reactants to form the stable complexes on thecathode surfaces. Maintaining a high degree of homogeneity in the fluidscirculated between the catalytic surfaces can also be helpful. Aconstant flow of about 2-8 mL/cm² per sec can be used, with typical meshelectrode distances 2 cm apart in large tanks. This flow can bemaintained, in part, by the convective flow of gasses released from theelectrodes during electrolysis.

The mixed solution, chilled or not, can then undergo electrochemicalprocessing through the use of at least one electrode in an electrolyzingstep. Each electrode can be or include a conductive metal. Metals caninclude, but are not limited to copper, aluminum, titanium, rhodium,platinum, silver, gold, iron, a combination thereof or an alloy such assteel or brass. The electrode can be coated or plated with a differentmetal such as, but not limited to aluminum, gold, platinum or silver. Inone embodiment, each electrode is formed of titanium and plated withplatinum. The platinum surfaces on the electrodes by themselves can beoptimal to catalyze the required reactions. Rough, double layeredplatinum plating can assure that local “reaction centers” (sharplypointed extrusions) are active and that the reactants not make contactwith the underlying electrode titanium substrate.

In one embodiment, rough platinum-plated mesh electrodes in a vertical,coaxial, cylindrical geometry can be optimal, with, for example, notmore than 2.5 cm, not more than 5 cm, not more than 10 cm, not more than20 cm, or not more than 50 cm separation between the anode and cathode.The amperage run through each electrode can be between about 2 amps andabout 15 amps, between about 4 amps and about 14 amps, at least about 2amps, at least about 4 amps, at least about 6 amps, or any range createdusing any of these values. In one embodiment, 7 amps is used with eachelectrode.

The amperage can be running through the electrodes for a sufficient timeto electrolyze the saline solution. The solution can be chilled duringthe electrochemical process. The solution can also be mixed during theelectrochemical process. This mixing can be performed to ensuresubstantially complete electrolysis.

Electric fields between the electrodes can cause movement of ions.Negative ions can move toward the anode and positive ions toward thecathode. This can enable exchange of reactants and products between theelectrodes. In some embodiments, no barriers are needed between theelectrodes.

After amperage has been run through the solution for a sufficient time,an electrolyzed solution is created. The solution can be stored and ortested for particular properties in storage/testing step.

The end products of this electrolytic process can react within thesaline solution to produce many different reactive oxygen species. ROScan include, but are not limited to superoxides (O₂*⁻, HO₂*),hypochlorites (OCl⁻, HOCl, NaClO), hypochlorates (HClO₂, ClO₂, HClO₃,HClO₄), oxygen derivatives (O₂, O₃, O₄*⁻, O), hydrogen derivatives (H₂,H⁻), hydrogen peroxide (H₂O₂), hydroxyl free radical (OH*⁻), ioniccompounds (Na⁺, Cl⁻, H⁺, OH⁻, NaCl, HCl, NaOH), chlorine (Cl₂), waterclusters (n*H₂O—induced dipolar layers around ions), and combinationsthereof. Some ROS can be electron acceptors and some can be electrondonors. In some embodiments, a reactive oxygen species is ahypochlorite. Some reactive oxygen species are electron acceptors andinclude HOCl, NaClO, O₂, H₂, H⁺, ClO, Cl₂, H₂O₂ and some are electrondonors and include O₂ ⁻, HO₂, Cl⁻, H⁻, *OCl, O₃, *O₂ ⁻ and OH⁻.

The chlorine concentration of the electrolyzed solution can be betweenabout 5 ppm and about 34 ppm, between about 10 ppm and about 34 ppm, orbetween about 15 ppm and about 34 ppm. In one embodiment, the chlorineconcentration is about 32 ppm.

The composition generally can include electrolytic and/or catalyticproducts of pure saline that mimic redox signaling molecularcompositions of native salt water compounds found in and around humancells. The composition can be fine-tuned to mimic or mirror molecularcompositions of different biological media. The composition can havereactive species other than chlorine present. As described, speciespresent in the compositions described herein can include, but are notlimited to O₂, H₂, Cl₂, OCl⁻, HOCl, NaOCl, HClO₂, ClO₂, HClO₃, HClO₄,H₂O₂, Na⁺, Cl⁻, H⁺, H⁻, OH⁻, O₃, O₄*⁻, ¹O₂, OH*⁻, HOCl—O₂*⁻, HOCl—O₃,O₂*⁻, HO₂*, NaCl, HCl, NaOH, and water clusters: n*H₂O-induced dipolarlayers around ions, and the like.

In some embodiments, the saline solution is electrolyzed to produce anamount of active species, which may include including ozone, activechlorine, active oxygen, or active hydrogen species. In someembodiments, the ozone is present in an amount of 0.1, 0.2, 0.3, 0.4,0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9,10, 15, 20, 25, 30, 35, 40, 45, 50,60, 70, 80, 90, 100, 150, 200, 250,or 300 ppm or an amount within a range defined by any two of theaforementioned values. In some embodiments, the active chorine speciesis present in an amount of 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35,40, 45, 50,60, 70, 80, 90, 100, 150, 200, 250, or 300 ppm or an amountwithin a range defined by any two of the aforementioned values. In someembodiments, the active chorine species is present in an amount of 0.1,0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5,5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50,60, 70, 80, 90, 100,150, 200, 250, or 300 ppm or an amount within a range defined by any twoof the aforementioned values. In some embodiments, the active oxygenspecies is present in an amount of 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7,0.8, 0.9, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 15, 20, 25,30, 35, 40, 45, 50,60, 70, 80, 90, 100, 150, 200, 250, or 300 ppm or anamount within a range defined by any two of the aforementioned values.In some embodiments, the active hydrogen species is present in an amountof 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.5, 2, 2.5, 3, 3.5,4, 4.5, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50,60, 70, 80,90, 100, 150, 200, 250, or 300 ppm or an amount within a range definedby any two of the aforementioned values. The process of electrolysis maybe performed using any suitable voltage, current, time, or conditions toprepare the saline solution according to the desired concentration ofactive species.

Pulsing potentials in the power supply of the production units can bebuilt into a system for making the composition. Lack of filtercapacitors in the rectified power supply can cause the voltages to dropto zero 120 times per second, resulting in a hard spike when thealternating current in the house power lines changes polarity. This hardspike, under Fourier transform, can emit a large bandwidth offrequencies. In essence, the voltage is varying from high potential tozero 120 times a second. In other embodiments, the voltage can vary fromhigh potential to zero about 1,000 times a second, about 500 times asecond, about 200 times a second, about 150 times a second, about 120times a second, about 100 times a second, about 80 times a second, about50 times a second, about 40 times a second, about 20 times a second,between about 200 times a second and about 20 times a second, betweenabout 150 times a second and about 100 times a second, at least about100 times a second, at least about 50 times a second, or at least about120 times a second. This power modulation can allow the electrodessample all voltages and also provides enough frequency bandwidth toexcite resonances in the forming molecules themselves. The time at verylow voltages can also provide an environment of low electric fieldswhere ions of similar charge can come within close proximity to theelectrodes. All of these factors together can provide a possibility forthe formation of stable complexes capable of generating and preservingROS free radicals.

Waveforms with an alternating current (AC) ripple can be used to providepower to the electrodes. Such an AC ripple can also be referred to aspulse or spiking waveforms and include: any positive pulsing currentssuch as pulsed waves, pulse train, square wave, saw tooth wave,pulse-width modulation (PWM), pulse duration modulation (PDM), singlephase half wave rectified AC, single phase full wave rectified AC orthree phase full wave rectified for example.

A bridge rectifier may be used. Other types of rectifiers can be usedsuch as Single-phase rectifiers, Full-wave rectifiers, Three-phaserectifiers, Twelve-pulse bridge, Voltage-multiplying rectifiers, filterrectifier, a silicon rectifier, an SCR type rectifier, a high-frequency(RF) rectifier, an inverter digital-controller rectifier, vacuum tubediodes, mercury-arc valves, solid-state diodes, silicon-controlledrectifiers and the like. Pulsed waveforms can be made with a transistorregulated power supply, a dropper type power supply, a switching powersupply and the like.

This pulsing waveform model can be used to stabilize superoxides,hydroxyl radicals and OOH* from many different components and is notlimited to any particular variable such as voltage, amps, frequency,flux (current density) or current. The variables are specific to thecomponents used. For example, water and NaCl can be combined whichprovide molecules and ions in solution. A 60 Hz current can be used,meaning that there are 60 cycles/120 spikes in the voltage (V) persecond or 120 times wherein the V is 0 each second. When the V goes downto 0 it is believe that the 0 V allows for ions to drift apart/migrateand reorganize before the next increase in V. Without wishing to bebound by theory, the spiking in V allows for and promotes a variablerange of frequencies influencing many different types of compoundsand/or ions.

Diodes may also be used. The V may drop to 0 as many times per second asthe frequency is adjusted. As the frequency is increased the number oftimes the V drops is increased.

When the ions are affected by the electricity from the electrodes, theychange. While still not wishing to be bound by theory, it is believedthat the electricity alters the state of some of the ions/compounds.This alteration results in the pushing of electrons out of theiroriginal orbit and/or spin state into a higher energy state and/or asingle spin state. This electrolysis provides the energy to form freeradicals which are ultimately formed during a multi-generational cyclingof reactants and products during the electrolysis process. In otherwords, compounds and/or ions are initially electrolyzed so that theproducts that are formed are then themselves reacted with othercompounds and/or ions and/or gas to form a second generation ofreactants and products. This generational process then happens again sothat the products from the second generation react with other compoundsand/or ions in solution when the voltage spikes again.

In some embodiments, the redox potential can be about 840 mV. In someembodiments, the frequency can be from about 1 Hz to infinity or toabout 100 MHz.

In some embodiments, end products of the electrolytic process can reactwithin the saline solution to produce different chemical entities. Thecompositions described herein can include one or more of these chemicalentities. These end products can include, but are not limited tosuperoxides: O₂*⁻, HO₂*; hypochlorites: OCl⁻, HOCl, NaOCl;hypochlorates: HClO₂, ClO₂, HClO₃, HClO₄; oxygen derivatives: O₂, O₃,O₄*⁻, ¹O; hydrogen derivatives: H₂, H⁻; hydrogen peroxide: H₂O₂;hydroxyl free Radical: OH*⁻; ionic compounds: Na⁺, Cl⁻, H⁺, OH⁻, NaCl,HCl, NaOH; chlorine: Cl₂; and water clusters: n*H₂O-induced dipolarlayers around ions, several variations.

To determine the relative concentrations and rates of production of eachof these during electrolysis, certain general chemical principles can behelpful:

1) A certain amount of Gibbs free energy is required for construction ofthe molecules; Gibbs free energy is proportional to the differences inelectrode potentials. Reactions with large energy requirements are lesslikely to happen, for example an electrode potential of −2.71 V(compared to hydrogen reduction at 0.00 V) is required to make sodiummetal: Na⁺+e⁻→Na(s).

Such a large energy difference requirement makes this reaction lesslikely to happen compared to other reactions with smaller energyrequirements. Electron(s) from the electrodes may be preferentially usedin the reactions that require lesser amounts of energy, such as theproduction of hydrogen gas.

2) Electrons and reactants are required to be at the same micro-localityon the electrodes. Reactions that require several reactants may be lesslikely to happen, for example: Cl₂+6 H₂O→10e⁻+2 ClO₃ ⁻+12 H⁺.

This reaction requires six water molecules and one Cl₂ molecule to be atthe electrode at the same point at the same time and a release of 10electrons to simultaneously occur. The probability of this happeninggenerally is smaller than other reactions requiring fewer and moreconcentrated reactants to coincide, but such a reaction may still occur.

3) Reactants generated in preceding generations can be transported ordiffuse to the electrode where reactions happen. For example, dissolvedoxygen (O₂) produced on the anode from the first generation can betransported to the cathode in order to produce superoxides and hydrogenperoxide in the second generation. Ions can be more readily transported:they can be pulled along by the electric field due to their electriccharge. In order for chlorates, to be generated, for example, HClO₂ canfirst be produced to start the cascade, restrictions for HClO₂production can also restrict any subsequent chlorate production. Lowertemperatures can prevent HClO₂ production.

Stability and concentration of the above products can depend, in somecases substantially, on the surrounding environment. The formation ofcomplexes and water clusters can affect the lifetime of the moieties,especially the free radicals.

In a pH-neutral aqueous solution (pH around 7.0) at room temperature,superoxide free radicals (O₂*⁻) have a half-life of 10's of millisecondsand dissolved ozone (O₃) has a half-life of about 20 minutes. Hydrogenperoxide (H₂O₂) is relatively long-lived in neutral aqueousenvironments, but this can depend on redox potentials and UV light.Other entities such as HCl and NaOH rely on acidic or basicenvironments, respectively, in order to survive. In pH-neutralsolutions, H⁺ and OH⁻ ions have concentrations of approximately 1 partin 10,000,000 in the bulk aqueous solution away from the electrodes. H⁻and ¹O can react quickly. The stability of most of these moietiesmentioned above can depend on their microenvironment.

Superoxides and ozone can form stable van der Waals molecular complexeswith hypochlorites. Clustering of polarized water clusters aroundcharged ions can also have the effect of preservinghypochlorite-superoxide and hypochlorite-ozone complexes. Such complexescan be built through electrolysis on the molecular level on catalyticsubstrates, and may not occur spontaneously by mixing togethercomponents. Hypochlorites can also be produced spontaneously by thereaction of dissolved chlorine gas (Cl₂) and water. As such, in aneutral saline solution the formation of one or more of the stablemolecules and complexes may exist: dissolved gases: O₂, H₂, Cl₂;hypochlorites: OCl⁻, HOCl, NaOCl; hypochlorates: HClO₂, ClO₂, HClO₃,HClO₄; hydrogen peroxide: H₂O₂; ions: Na⁺, Cl⁻, H⁺, H⁻, OH⁻; ozone: O₃,O₄*⁻; singlet oxygen: ¹O; hydroxyl free radical: OH*⁻; superoxidecomplexes: HOCl—O₂*⁻; and ozone complexes: HOCl—O₃. One or more of theabove molecules can be found within the compositions described herein.

A complete quantum chemical theory can be helpful because production iscomplicated by the fact that different temperatures, electrodegeometries, flows and ion transport mechanisms and electrical currentmodulations can materially change the relative/absolute concentrationsof these components, which could result in producing different distinctcompositions. As such, the selection of production parameters can becritical. The amount of time it would take to check all the variationsexperimentally may be prohibitive.

The chlorine concentration of the electrolyzed solution can be about 5ppm, about 10 ppm, about 15 ppm, about 20 ppm, about 21 ppm, about 22ppm, about 23 ppm, about 24 ppm, about 25 ppm, about 26 ppm, about 27ppm, about 28 ppm, about 29 ppm, about 30 ppm, about 31 ppm, about 32ppm, about 33 ppm, about 34 ppm, about 35 ppm, about 36 ppm, about 37ppm, about 38 ppm, less than about 38 ppm, less than about 35 ppm, lessthan about 32 ppm, less than about 28 ppm, less than about 24 ppm, lessthan about 20 ppm, less than about 16 ppm, less than about 12 ppm, lessthan about 5 ppm, between about 30 ppm and about 34 ppm, between about28 ppm and about 36 ppm, between about 26 ppm and about 38 ppm, betweenabout 20 ppm and about 38 ppm, between about 5 ppm and about 34 ppm,between about 10 ppm and about 34 ppm, or between about 15 ppm and about34 ppm. In one embodiment, the chlorine concentration is about 32 ppm.In another embodiment, the chlorine concentration is less than about 41ppm.

The saline concentration in the electrolyzed solution can be about 0.10%w/v, about 0.11% w/v, about 0.12% w/v, about 0.13% w/v, about 0.14% w/v,about 0.15% w/v, about 0.16% w/v, about 0.17% w/v, about 0.18% w/v,about 0.19% w/v, about 0.20% w/v, about 0.30% w/v, about 0.40% w/v,about 0.50% w/v, about 0.60% w/v, about 0.70% w/v, between about 0.10%w/v and about 0.20% w/v, between about 0.11% w/v and about 0.19% w/v,between about 0.12% w/v and about 0.18% w/v, between about 0.13% w/v andabout 0.17% w/v, or between about 0.14% w/v and about 0.16% w/v.

The composition generally can include electrolytic and/or catalyticproducts of pure saline that mimic redox signaling molecularcompositions of the native salt water compounds found in and aroundhuman cells. The composition can be fine-tuned to mimic or mirrormolecular compositions of different biological media. The compositioncan have reactive species other than chlorine present. As described,species present in the compositions described herein can include, butare not limited to O₂, H₂, Cl₂, OCl⁻, HOCl, NaOCl, HClO₂, ClO₂, HClO₃,HClO₄, H₂O₂, Na⁺, Cl⁻, H⁺, H⁻, OH⁻, O₃, O₄*⁻, ¹O, OH*⁻, HOCl—O₂*⁻,HOCl—O₃, O₂*, HO₂*, NaCl, HCl, NaOH, and water clusters: n*H₂O—induceddipolar layers around ions, several variations.

In some embodiments, hydroxyl radicals can be stabilized in thecomposition by the formation of radical complexes. The radical complexescan be held together by hydrogen bonding. Another radical that can bepresent in the composition is an OOH* radical. Still other radicalcomplexes can include a nitroxyl-peroxide radical (HNO—HOO*) and/or ahypochlorite-peroxide radical (HOCl—HOO*).

Concentrations of reactive species in the electrolyzed saline solutions,detected by fluorescence photo spectroscopy, may not significantlydecrease in time. Mathematical models show that bound HOCl—*O₂ ⁻complexes are possible at room temperature. Molecular complexes canpreserve volatile components of reactive species. For example, reactivespecies concentrations in whole blood as a result of molecular complexesmay prevent reactive species degradation over time.

The electrolyzed saline solution having reactive oxygen species mayfurther be mixed with a rheology agent.

III. Methods of Use of a Composition

The composition provided herein may be prepared, packaged, or sold informulations for oral, injectable, or topical administration. Thecomposition can be filled into suitable packaging (containers) such as,for example, syringes, tubes, cartons, capsule, jars, bottles,canisters, squeeze pack, pouches, packages, packets, sacks, tank, orother containers. In some embodiments, the composition may be ingested,injected, or may be applied directly to skin. In some embodiments, thecomposition may be applied by an applicator, a brush, or other devicefor application to the skin.

For oral application, the composition may be formulated as a liquid, agel, or other composition suitable for ingestion. Similarly, forinjection, the composition may be formulated as a solution or liquidinjectable suitable for parenteral administration (for example,subcutaneous, intravenous, intramuscular, intramedullary, intrathecal,or other composition for parenteral administration). In someembodiments, the composition is administered orally or parenterally inounce units such as from 0.1 oz. to 20 oz. or as desired by the subject.Each administration can be about 0.1 oz., 0.2 oz., 0.3 oz., 0.4 oz., 0.5oz., 0.6 oz., 0.7 oz., 0.8 oz., 0.9 oz., 1 oz., about 2 oz., about 3oz., about 4 oz., about 5 oz., about 6 oz., about 7 oz., about 8 oz.,about 9 oz., about 10 oz., about 11 oz., about 12 oz., about 16 oz., orabout 20 oz. The composition can be administered once, twice, threetimes, four times or more a day. In one embodiment, the compositionadministered at a rate of about 4 oz. twice a day. In some embodiments,the composition formulated for oral administration is provided oradministered to a subject as a beverage. In some embodiments, the oralformulation exhibits superior taste. In some embodiments, the beverageimproves endurance, improves metabolic activity, increases energy,increases health and well-being, improves hydration, treats orameliorates a disease or disorder, or combats metabolic syndrome.

In some embodiments, the composition is formulated for topicalapplication, for example to be applied directly to skin, such as aregion of skin that would that would benefit from application. In otherembodiments, the composition is applied directly to the skin by one ormore of a dropper, an applicator stick, as a mist or aerosol, as atransdermal patch, by wiping with a wipe, or by spreading thecomposition on the area with fingers or other applicators. Thecomposition can be applied to the skin in any suitable therapeuticamount. In some embodiments, the composition is administered and/orapplied to the skin in ounce units such as from 0.1 oz. to 20 oz. or asdesired by the subject. Each application to the skin can be about 0.1oz., 0.2 oz., 0.3 oz., 0.4 oz., 0.5 oz., 0.6 oz., 0.7 oz., 0.8 oz., 0.9oz., 1 oz., about 2 oz., about 3 oz., about 4 oz., about 5 oz., about 6oz., about 7 oz., about 8 oz., about 9 oz., about 10 oz., about 11 oz.,about 12 oz., about 16 oz., or about 20 oz. When applied to the skin, itcan be applied once, twice, three times, four times or more a day. Inone embodiment, the composition is applied to the skin at a rate ofabout 4 oz. twice a day. In some embodiments, the composition formulatedfor topical administration is provided or administered to a subject. Insome embodiments, the topical formulation exhibits superior smoothnessor lubricity. In some embodiments, the topical formulation improves theappearance of skin, reduces wrinkles or spots, increases skinelasticity, improves health and wellness, or treats or ameliorates adisease or disorder.

Packaging can include single use aliquots in single use packaging suchas pouches. The composition can be packaged in suitable packaging havingvolumes of about 0.1 oz., about 0.2 oz., about 0.5 oz., about 1 oz.,about 2 oz., about 4 oz., about 8 oz., about 16 oz., about 32 oz., about48 oz., about 64 oz., about 80 oz., about 96 oz., about 112 oz., about128 oz., about 144 oz., about 160 oz., or an amount within a rangedefined by any two of the aforementioned values. The packaging can alsobe squeezable pouches having similar volumes.

In some embodiments, packaging may be free of dyes, metal specks, orchemicals that can be dissolved by acids or oxidizing agents. In otherembodiments, any bottles, package caps, bottling filters, valves, lines,and heads used in packaging may be specifically rated for acids andoxidizing agents. In some cases, package caps with any organic glues,seals, or other components sensitive to oxidation may be avoided sincethey could neutralize and weaken the product over time.

As used herein, a “subject” or a “patient” refers to an animal that isthe object of treatment, administration, observation, or experiment.“Animal” comprises cold-and warm-blooded vertebrates and invertebratessuch as fish, shellfish, reptiles and, in particular, mammals. “Mammal”comprises, without limitation, mice, rats, rabbits, guinea pigs, dogs,cats, sheep, goats, cows, horses, primates, such as monkeys,chimpanzees, and apes, and, in particular, humans. In some alternatives,the subject is human.

Some embodiments disclosed herein relate to selecting a subject orpatient in need. In some embodiments, a patient is selected who is inneed of treatment, amelioration, inhibition, progression, prophylaxis,or improvement in disease symptoms or who is in need of curativetherapy. In some embodiments, a patient is selected who would benefitfrom application of a composition having reactive oxygen speciestherein. Such identification or selection of said subjects or patientsin need can be made through clinical and/or diagnostic evaluation. Insome embodiments, a subject is selected who does not have a diseasecondition, but who wishes to prevent a disease condition.

The term “therapeutically effective amount” is used to indicate anamount of a composition that elicits the biological or medicinalresponse indicated. For example, a therapeutically effective amount of acomposition can be the amount needed to prevent, alleviate, orameliorate a disease or condition or an appearance of a disease orcondition. Determination of a therapeutically effective amount is withinthe capability of those skilled in the art, in view of the disclosureprovided herein. The therapeutically effective amount of the compositiondisclosed herein required as a dose will depend on the route ofadministration, the type of animal, including human, being treated, andthe physical characteristics of the specific animal under consideration.The dose can be tailored to achieve a desired effect, but will depend onsuch factors as weight, diet, concurrent medication and other factorswhich those skilled in the medical arts will recognize.

In some embodiments, a dose is provided in an amount of about 0.1 ounceto about 12 ounces, such as 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 ounces, or an amount within arange defined by any two of the aforementioned values. In someembodiments, the dose is administered at a frequency of four times dailyto one time monthly, such as 4 times/day, 3 times/day, 2 times/day, 1time/day, once every other day, 6 times/week, 5 times/week, 4times/week, 3 times/week, 2 times/week, 1 time/week, once every otherweek, twice monthly, or once monthly, or an amount within a rangedefined by any two of the aforementioned frequencies. In someembodiments, the dose is administered for a period of one day to 10years or more, for example, for a period of one day, one week, onemonth, six months, one year, two years, three years, four years, fiveyears, six years, seven years, eight years, nine years, ten years, ormore, or within a range defined by any two of the aforementioned values.

As used herein, the term “coadministration” of pharmacologically activecompounds refers to the delivery of two or more separate chemicalentities or separate therapies, whether in vitro or in vivo.Coadministration refers to the simultaneous delivery of separate agentsor therapies; to the simultaneous delivery of a mixture of agents; tothe delivery of one agent followed by delivery of a second agent oradditional agents; or to the administration of one therapy followed byor concomitant with another therapy. In all cases, agents or therapiesthat are coadministered are intended to work in conjunction with eachother. Similarly, in the context of administration of more than onecompound, the term “in combination” refers to a concomitant delivery ofone compound with one or more compounds. The compounds may beadministered in combination by simultaneous administration oradministration of one compound before or after administration of anothercompound.

In some embodiments, the composition may be administered or appliedalone, in the absence of other treatments, therapies, or agents or incombination with one or more therapy for the treatment of a disease orcondition.

In some embodiments, the composition may be applied directly into theskin, and therefore, the composition may be formulated for topicalapplication. Accordingly, the composition may have any suitable form fortopical administration. In some embodiments the composition is in theform of a cream, a hydrogel, a lotion, a gel, a serum, a liquid, a foam,a mist, or an ointment. In some embodiments, the composition may beformulated for intradermal or subcutaneous administration.

The disclosure is generally described herein using affirmative languageto describe the numerous embodiments. The disclosure also includesembodiments in which subject matter is excluded, in full or in part,such as substances or materials, method steps and conditions, protocols,or procedures.

EXAMPLES

Some aspects of the embodiments discussed above are disclosed in furtherdetail in the following examples, which are not in any way intended tolimit the scope of the present disclosure. Those in the art willappreciate that many other embodiments also fall within the scope of thedisclosure, as it is described herein above and in the claims.

Example 1 Preparation of Redox Compositions

The following example describes an embodiment of a composition andmethods of making the composition.

A composition was prepared with the ingredients as provided in Table 1.The ingredients provided below were added to saline solution, with afinal pH adjusted to 6.5-7.0. The saline solution was prepared with0.05% salt.

TABLE 1 Reactive Oxygen Composition Ingredient Final % wt/vol Role inComposition Electrolyzed Saline Solution 94.628 Base (0.05% salt)Dimethicone Satin 5 Emollient Sodium Hypochlorite (4.99%) 0.072 Reactiveoxygen species Sodium Phosphate Monobasic 0.3 pH modifier

Refined salts, such as table salts can be used to prepare the salinesolution, which may include the components listed in Table 2.

TABLE 2 Refined table salt components used in saline solution ElementQuantity (ppm) Aluminum 0.747 Antimony 0.014 Arsenic 0.039 Barium 0.012Beryllium 0.038 Bismuth 0.005 Bromide 81.414 Cadmium 0.007 Calcium10.625 Chromium 0.027 Cobalt 0.001 Copper 0.053 Germanium 0.081 Iodide<0.001 Iron 0.639 Lead 25.908 Magnesium 3.753 Manganese 0.040 Mercury0.013 Molybdenum 0.007 Nickel 0.016 Phosphorus 3.690 Potassium 60.756Selenium 0.202 Silver 0.002 Sodium 391,290 Strontium 0.230 Tin 0.166Zinc 0.791

The salt composition described in Table 2 is refined table salt, and thequantity of elements was determined by inductively couple plasma massspectrometry (ICP-MS). Teachings in the art suggest that only purified,refined salts may be used in a saline solution having reactive oxygenspecies, such as hypochlorite, and that raw or unprocessed salts areincompatible for use in a saline solution having reactive oxygenspecies. Thus, not only can raw, unprocessed salts be used in the salinesolution, but raw, unprocessed salts result in improved compositionsthat function unexpectedly superior to compositions prepared usingtraditional refined salts. The components for the improved saltcomposition using raw salt are provided in Table 3, in three separatesalt compositions.

TABLE 3 Raw salt components used in saline solution Composition 1Composition 2 Composition 3 Element Quantity (ppm) Aluminum 114.8 32.473241.700 Antimony 0.022 0.013 0.026 Arsenic 0.066 0.046 0.076 Barium0.664 0.343 7.615 Beryllium 0.051 0.030 0.070 Bismuth 0.005 0.004 0.006Bromide 56.006 70.607 7.789 Cadmium 0.017 0.010 0.024 Calcium 2101.0001290.000 1860.000 Chromium 0.207 0.195 0.175 Cobalt 0.033 0.013 0.058Copper 0.116 0.090 0.279 Germanium 0.072 0.085 0.092 Iodide <0.001<0.001 <0.001 Iron 81.722 23.292 141.400 Lead 0.093 0.077 0.210Magnesium 1944.000 1304.000 217.900 Manganese 1.911 1.040 11.804 Mercury0.016 0.009 0.012 Moly bdenum 0.011 0.014 0.037 Nickel 0.096 0.086 0.113Phosphorus 5.125 3.548 9.541 Potassium 1728.000 1174.000 149.300Selenium 0.269 0.235 0.226 Silver 0.004 0.002 0.006 Sodium 388690.000391706.000 390600.000 Strontium 32.223 18.328 11.251 Tin 0.169 0.1350.177 Zinc 1.261 1.045 1.883

The raw salt compositions provided in Table 3 were analyzed by ICP-MS todetermine the quantity of elements. The salt compositions used werevarious types of raw sea salt (compositions 1 and 2—Himalayan pink seasalt; composition 3—sea salt).

The composition described in Table 1 exhibits unexpectedly superiorresults when the saline solution is prepared using a salt provided inTable 3, or other forms of raw salt described herein.

Example 2 Preparation of Gel Compositions

The following example describes an embodiment of a gel composition andmethods of making the composition.

A gel composition was prepared using as described in Example 1 thatfurther includes a rheology agent as provided in Table 4. Theingredients were added to the saline solution, with a final pH adjustedto 6.5-7.0. The saline solution was prepared with 0.05% salt, using theraw salt components described in Example 1.

TABLE 4 Gel Composition Ingredient Final % wt/vol Role in CompositionElectrolyzed Saline Solution 91.378 Base (0.05% salt) Laponite XLG 3.25Rheology agent Dimethicone Satin 5 Emollient Sodium Hypochlorite (4.99%)0.072 Reactive oxygen species Sodium Phosphate Monobasic 0.3 pH modifier

Thus, not only can raw, unprocessed salts be used in the salinesolution, but raw, unprocessed salts result in improved gel compositionsthat function unexpectedly superior to gel compositions prepared usingtraditional refined salts.

Example 3 Improved Oral Compositions

The following example describes methods of use of a composition asdescribed herein formulated as a beverage for oral consumption.

An oral composition is formulated as described herein having anelectrolyzed saline solution with a raw salt of Table 3. The compositionis provided to subjects for oral consumption, who provide feedback onthe formulation related to the taste of the formulation and to theirgeneral well-being and health following consumption of the formulationover a treatment period. Each subject is instructed to consume theformulation in an amount of 0.1 oz. to 20 oz., once, twice, three times,four times or more a day for the treatment period.

Control subjects are provided a control formulation having anelectrolyzed saline solution with a refined salt as listed in Table 2,or are provided with beverages known in the art. The control subjectsare instructed to provide feedback on the formulation related to thetaste of the formulation and to their general well-being and healthafter consumption of the formulation over the treatment period.

The feedback from both the test and control subjects is collected andresults are compared for the test and control formulation. The testformulation having the raw salts of Table 3 exhibits unexpectedlysuperior properties as compared to the control formulation havingrefined salts of Table 2. Furthermore, the test formulation exhibitsimproved properties as compared to existing beverages known in the art.Specifically, the test formulation having raw salts exhibits improvedtaste, provides greater endurance for the subject, provides greaterenergy for the subject, more effectively combats metabolic syndrome,provides better hydration, and increases the general health andwell-being of the subject as compared to the control formulation and ascompared to beverages known in the art. Thus, the oral formulationhaving raw unprocessed salts exhibits unexpectedly superior results ascompared to the control formulation and as compared to beverages knownin the art.

Example 4 Improved Topical Compositions

The following example describes methods of use of a composition asdescribed herein formulated for topical application.

A topical composition is formulated as described in Table 4 having a rawsalt described in Table 3. The composition is provided to subjects, whoprovide feedback on the formulation related to the feel and texture ofthe formulation and to improvements in physical appearance of skin afterusing the formulation over a treatment period. Each subject isinstructed to apply the formulation in an amount of 0.1 oz. to 20 oz.,once, twice, three times, four times or more a day for the treatmentperiod.

The test formulation having the raw salts of Table 4 provides superiorsmoothness when provided topically to skin, assists in reducing wrinklesor spots, and improves the overall appearance of skin. Thus, the gelcomposition described in Table 4 exhibits unexpectedly superior resultswhen the saline solution is prepared using a raw unprocessed salt.

The formulations described in Examples 1-4 having raw unprocessed salts(such as those described in Table 3) exhibits additional surprisingcharacteristics. In particular, the method of manufacture of theelectrolyzed saline solution is more efficient using raw unprocessedsalts as compared to compositions prepared using refined salts.Furthermore, the compositions exhibit improved stability as compared tocompositions prepared using refined salts. For example, the compositionsremain stable for at least 3 months, at least 6 months, at least 9months, at least 12 months, at least 15 months, at least 18 months, atleast 21 months, at least 24 months, at least 30 months, at least 50months, at least 100 months, or longer, and exhibit improved stabilitycompared to compositions formulated using refined salts.

In at least some of the previously described embodiments, one or moreelements used in an embodiment can interchangeably be used in anotherembodiment unless such a replacement is not technically feasible. Itwill be appreciated by those skilled in the art that various otheromissions, additions and modifications may be made to the methods andstructures described above without departing from the scope of theclaimed subject matter. All such modifications and changes are intendedto fall within the scope of the subject matter, as defined by theappended claims.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (for example, bodiesof the appended claims) are generally intended as “open” terms (forexample, the term “including” should be interpreted as “including butnot limited to,” the term “having” should be interpreted as “having atleast,” the term “includes” should be interpreted as “includes but isnot limited to,” etc.). It will be further understood by those withinthe art that if a specific number of an introduced claim recitation isintended, such an intent will be explicitly recited in the claim, and inthe absence of such recitation no such intent is present. For example,as an aid to understanding, the following appended claims may containusage of the introductory phrases “at least one” and “one or more” tointroduce claim recitations. However, the use of such phrases should notbe construed to imply that the introduction of a claim recitation by theindefinite articles “a” or “an” limits any particular claim containingsuch introduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (for example, “a” and/or “an” should be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould be interpreted to mean at least the recited number (for example,the bare recitation of “two recitations,” without other modifiers, meansat least two recitations, or two or more recitations). Furthermore, inthose instances where a convention analogous to “at least one of A, B,and C, etc.” is used, in general such a construction is intended in thesense one having skill in the art would understand the convention (forexample, “a system having at least one of A, B, and C” would include butnot be limited to systems that have A alone, B alone, C alone, A and Btogether, A and C together, B and C together, and/or A, B, and Ctogether, etc.). In those instances where a convention analogous to “atleast one of A, B, or C, etc.” is used, in general such a constructionis intended in the sense one having skill in the art would understandthe convention (for example, “a system having at least one of A, B, orC” would include but not be limited to systems that have A alone, Balone, C alone, A and B together, A and C together, B and C together,and/or A, B, and C together, etc.). It will be further understood bythose within the art that virtually any disjunctive word and/or phrasepresenting two or more alternative terms, whether in the description,claims, or drawings, should be understood to contemplate thepossibilities of including one of the terms, either of the terms, orboth terms. For example, the phrase “A or B” will be understood toinclude the possibilities of “A” or “B” or “A and B.”

In addition, where features or aspects of the disclosure are describedin terms of Markush groups, those skilled in the art will recognize thatthe disclosure is also thereby described in terms of any individualmember or subgroup of members of the Markush group.

As will be understood by one skilled in the art, for any and allpurposes, such as in terms of providing a written description, allranges disclosed herein also encompass any and all possible sub-rangesand combinations of sub-ranges thereof. Any listed range can be easilyrecognized as sufficiently describing and enabling the same range beingbroken down into at least equal halves, thirds, quarters, fifths,tenths, etc. As a non-limiting example, each range discussed herein canbe readily broken down into a lower third, middle third and upper third,etc. As will also be understood by one skilled in the art all languagesuch as “up to,” “at least,” “greater than,” “less than,” and the likeinclude the number recited and refer to ranges which can be subsequentlybroken down into sub-ranges as discussed above. Finally, as will beunderstood by one skilled in the art, a range includes each individualmember. Thus, for example, a group having 1-3 articles refers to groupshaving 1, 2, or 3 articles. Similarly, a group having 1-5 articlesrefers to groups having 1, 2, 3, 4, or 5 articles, and so forth.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art.The various aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting, with the true scopeand spirit being indicated by the following claims.

What is claimed is:
 1. A composition, comprising: an electrolyzed salinesolution, wherein the electrolyzed saline solution comprises Himalayansea salt present in an amount of about 0.01% to about 15% w/v; areactive oxygen species comprising hypochlorite, wherein thehypochlorite is present in an amount of about 60 to about 100 ppm; anemollient; and a pH modifier; the composition comprising an osmolalitymeasurement value between about 0.5 and 100 mOsm/kg.
 2. The compositionof claim 1, wherein the osmolality measurement value is about 3 to 5mOsm/kg.
 3. The composition of claim 1, wherein the Himalayan sea saltis present in an amount of 0.05%, wherein the hypochlorite is present inan amount of 72 ppm, wherein the emollient is a silicone polymer presentin an amount of 5% wt/vol, wherein the pH modifier is sodium phosphatemonobasic present in an amount of 0.3% wt/vol, and further comprisingsodium magnesium silicate present in an amount of 3.25% wt/vol.
 4. Thecomposition of claim 1, wherein the electrolyzed saline solution ispresent in an amount of 94.628% final wt/vol and comprises salt in anamount 0.05%, wherein the emollient comprises silicone polymer presentin an amount of 5% final wt/vol, wherein the hypochlorite is present inan amount of 0.072% final wt/vol, and wherein the pH modifier is sodiumphosphate monobasic present in an amount of 0.3% final wt/vol.
 5. Thecomposition of claim 1, wherein the electrolyzed saline solution ispresent in an amount of 91.378% final wt/vol and comprises salt in anamount of 0.05%, wherein the emollient comprises silicone polymerpresent in an amount of 5% final wt/vol, wherein the hypochlorite ispresent in an amount of 0.072% final wt/vol, wherein the pH modifier issodium phosphate monobasic present in an amount of 0.3% final wt/vol,and further comprising sodium magnesium silicate present in an amount of3.25% final wt/vol, wherein the composition is formulated as a gel. 6.The composition of claim 1 further comprising: sodium magnesium silicatepresent in an amount of about 3% wt/vol; and an additive selected fromthe group consisting of moisturizers, humectants, pigments, dyes,pearlescent compounds, nacreous pigments, bismuth oxychloride coatedmica, titanium dioxide coated mica, colorants, fragrances, biocides,preservatives, lipolytic agents, diuretics, xanthines, alpha hydroxylacids, antioxidants, lymphatic drainage agents, antiperspirant agents,exfoliants, hormones, enzymes, medicinal compounds, vitamins, minerals,electrolytes, alcohols, polyols, polypropylene glycol, retinoids,retinol, polyisobutene, polyoxyethylene, behenic acid, behenyl,sugar-alcohols, absorbing agents for ultraviolet radiation, botanicalextracts, surfactants, silicone oils, organic oils, waxes, alkaline oracidic or buggering agents, film formers, thickening agents, hyaluronicacid, fumed silica, hydrated silica, talc, kaolin, starch, modifiedstarch, mica, nylon, clay, bentonite, organo-modified clays, andcombinations thereof, wherein the composition is formulated as a topicalformulation.
 7. The composition of claim 1, wherein the composition hasa pH ranging from about 6.0 to about 7.8.
 8. The composition of claim 1,further comprising superoxides, hypochlorites, hypochlorates, oxygenderivatives, hydrogen derivatives, hydrogen peroxide, hydroxyl freeradical, ionic compounds, chlorine, and water clusters.
 9. Thecomposition of claim 1, wherein the composition is formulated as a gel,sol, sol-gel, hydrogel, cream, foam, balm, liniment, unguent, colloid,emulsion, dispersion, salve, emollient, lotion, meltable solid, mousse,ointment, paste, serum, solution, liquid, spray, stick, or suspension.10. The composition of claim 3, wherein the silicone polymer isamodimethicone, dimethicone, cyclomethicone, cyclodimethicone,iso-dimethicone copolymer, or a blend thereof.
 11. The composition ofclaim 5, wherein the gel has a viscosity ranging from about 100 to about100,000 centipoise (cP).
 12. The composition of claim 6, wherein theexfoliant comprises lactic acid, glycolic acid, malic acid, tartaricacid, citric acid, salicylic acid, lactobionic acid, or gluconic acid.13. The composition of claim 1, wherein the electrolyzed saline solutioncomprises ozone in an amount of about 0.1 to 300 ppm, active chlorinespecies in an amount of about 0.1 to 300 ppm, active oxygen species inan amount of about 0.1 to 300 ppm, and active hydrogen species in anamount of about 0.1 to 300 ppm.
 14. The composition of claim 1, whereinthe electrolyzed saline solution has a redox potential of 840 mV. 15.The composition of claim 1, wherein the composition is formulated in adosage amount ranging from about 0.1 ounce to about 12 ounces.
 16. Thecomposition of claim 1, wherein the composition comprises: Himalayansalt in an amount of about 0.05% w/v; hypochlorite in an amount of about72 ppm; dimethicone in an amount of about 5% w/v; and sodium phosphatemonobasic in an amount of about 0.3% w/v, wherein the composition has apH ranging from about 6.5 to about 7.0.
 17. The composition of claim 16,wherein the composition is a gel composition and further comprisessodium magnesium silicate in an amount of about 3.25% w/v.